NCT00980980

Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs)

Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74,256 (actual)
• Sponsor: Harvard Pilgrim Health Care · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are: * screening on admission followed by isolation of MRSA+ patients * screening on admission followed by isolation and decolonization of MRSA+ patients * universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures. The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.

Detailed description

Baseline data involving 12 months of data for participating hospitals (July 2008 - June 2009) was collected prior to randomization to account for size and ICU baseline prevalence of MRSA in randomization scheme. Randomization occurred at the hospital level. Eligibility survey was conducted to determine exclusion criteria. As of May 2010, enrollment has been closed. 45 hospitals were randomized, but two were found to meet exclusion criteria and were excluded. As-randomized (or as-assigned) analysis included 43 hospitals, representing 74 ICUs. Individual (patient-level) subject enrollment during intervention is 74,256.

Conditions

• Methicillin-resistant Staphylococcus Aureus

Interventions

Type	Name	Description
DRUG	Chlorhexidine bath and nasal mupirocin	The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-09-21
• Last updated: 2017-05-02
• Results posted: 2014-07-30

Locations

42 sites across 1 country: United States